A clinical trial comparing the Intra ocular pressure lowering eficacy of Travoprost / Brinzolamide Fixed Combination vs TRAVATAN and vs AZOPT in Patients with open Angle Glaucoma or Ocular Hypertensio
- Conditions
- Health Condition 1: null- Open angle Glaucoma ,Ocular Hypertension
- Registration Number
- CTRI/2008/091/000301
- Lead Sponsor
- Alcon Research ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 50
18 years of age or older
Either gender and any race
OAG or OHT
Currently on a stable (i.e., at least 4 weeks) IOP-lowering medication
IOP at Screening Visit ≥ 18 mmHg in at least one eye
Mean IOP in same eye (at both Eligibility 1 & 2 Visits)
≥ 24 and ≤ 36 mmHg at 9 AM
≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM
Able to discontinue use of IOP-lowering medication for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit 1
Related to disease condition being investigated (OAG or OH) in either eye:
- Severe central visual field loss
- Angle Shaffer grade < 2
- Cup/disc ratio > 0.8 (horizontal or vertical measurement)
Related to ocular patient history or current ocular condition in either eye:
- Best corrected VA score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
- Ocular infection or inflammation or laser surgery within last 3 months
- Intraocular surgery or trauma within last 6 months
- Any abnormality preventing reliable applanation tonometry
- History of chronic, recurrent or current severe inflammatory disease
- History of or current clinically significant or progressive retinal disease
- History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study
Related to systemic or ocular medication in either eye
- Allergy/hypersensitivity to study medications
- Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period
- Use of oral CAIs during the study
- Recent use (< 4 weeks prior to the study) of Aspirin (> 1 gram)
- Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP
- Therapy with another investigational agent within 30 days prior to the Screening visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean IOPTimepoint: at the 9:00, 11:00 and 16:00 time points at Week 12
- Secondary Outcome Measures
Name Time Method Mean diurnal IOP at Week 12Timepoint: Mean diurnalresults pooled across the 9:00, 11:00 and 16:00 time points will be performed.